Observational Prospective Analysis of Biological Characteristics of Mesothelioma Patients
Diagnostic and Prognostic Role of New Inflammation Biomarkers in Patients With Malignant Pleural Mesothelioma
1 other identifier
observational
100
1 country
2
Brief Summary
This is an observational prospective analysis of biological characteristics of malignant mesothelioma (MM) patients. Frozen and paraffin-embedded tumor specimens and pleural effusion of patients will be collected and than will be analyzed with the following analyses: 1Purification of Tumour Associated Macrophages (TAM) and tumour cells from pleural effusions. 2.Mass spectrometry analysis of TAMs and tumor cells 3.Co focal microscopy analysis of macrophages, tumour cells and specimens derived from patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2011
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 27, 2013
CompletedFirst Posted
Study publicly available on registry
November 25, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2018
CompletedSeptember 9, 2022
September 1, 2022
6.7 years
May 27, 2013
September 8, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
dissect the molecular mechanisms underlying the development of malignant mesothelioma
characterization of the microenvironment (expression of M1 and M2 markers of polarized inflammation - cytokines and chemokines inducers or inhibitors of the inflammatory response) and the interplay between tumour cells and TAMs (expression of DNA damage markers) in order to dissect the molecular mechanisms underlying the development of malignant mesothelioma
24 months
Secondary Outcomes (5)
study of the effect of TAMs
24 months
investigation of molecular mechanisms linking macrophages
24 months
molecular characterization (proteome) of TAMs and tumor cells
24 months
compare in specimens from mesothelioma patients and the candidate molecular markers
24 months
Investigate the association of selected markers with Overall Survival
24 months
Study Arms (1)
no treatment
no treatment
Eligibility Criteria
Malignant pleural mesothelioma patients
You may qualify if:
- Malignant pleural mesothelioma patients
- Availability of plural effusion and frozen and paraffin-embedded tumor specimens.
You may not qualify if:
- Unavailability of plural effusion and frozen and paraffin-embedded tumor specimens.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Istituto Clinico Humanitas
Rozzano, Milano, 20089, Italy
Istituto Clinico Humanitas
Rozzano, Milan, 20089, Italy
Biospecimen
pleural effusion
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
armando Santoro, MD
Istituto Clinico Humanitas
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 27, 2013
First Posted
November 25, 2014
Study Start
April 1, 2011
Primary Completion
December 1, 2017
Study Completion
January 1, 2018
Last Updated
September 9, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will not share
not planned